MalfunctionBSZ
ADU
Received Oct 18, 2016 · Event occurred Sep 19, 2016
Report 9610105-2016-00056 · MDR key 6036513
Device
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
NO REPORT OF PATIENT INVOLVEMENT. DATE OF DEVICE MANUFACTURE YEAR IS 2003. THE MONTH OF MANUFACTURE WAS AUGUST. A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE STATED ISSUE. THE BELLOWS BLOCK WAS FOUND TO BE LEAKING. THE BLOCK WAS RESEATED TO RESOLVE THE REPORTED ISSUE.
Description of Event or Problem
THE HOSPITAL REPORTED THAT, THE UNIT HAS HIGH LEAKAGE. HIGH LEAK FAILED ON THE MANUAL VENTILATION TEST. THERE WAS NO REPORTED PATIENT INVOLVEMENT.